Medical device with time-controlled start function

ABSTRACT

A medical device having a time-controlled start function and a control unit, which enables user-friendly operation of the medical device, is described. The medical device has a control unit, which is equipped for automatic start-up of the medical device at a predetermined point in time and for checking on whether, after start-up of the medical device, a predetermined event has occurred, and has a display screen for display of information when the check reveals that the event has not occurred. Furthermore, a corresponding process for user-friendly operation is described.

FIELD OF THE INVENTION

The invention relates to a medical device having a time-controlled startfunction and a control unit, which permits a user-friendly operation ofthe medical device.

BACKGROUND

Medical devices regularly require one or more actions that must becarried out before treatment of a patient can begin. To reduce theworkload for the operator of the machine or to permit good utilizationof equipment, medical devices have a time-controlled start function(auto-on).

After a predetermined period of time has elapsed or at a predeterminedpoint in time, for example, a certain time of day, the machine startsautomatically and automatically carries out at least one action.Automatic here is to be understood to mean that this action takes placewithout interaction by an operator.

Such an auto-on function is known, for example, for hemodialysismachines in which before the treatment, the liquid system through whichwater and/or dialysate flows during the treatment (hydraulic system) iscleaned.

This action may involve, for example, a cleaning process with which aliquid circulation of a hemodialysis machine can be cleaned before thetreatment. Such a process is described, for example, in U.S. Pat. No.4,789,467 A.

It has been found that this auto-on function can be simplified withregard to use.

DESCRIPTION OF THE INVENTION

The object is therefore to supplement the auto-on function with regardto user friendliness.

This object is achieved by means of a medical device and/or a processaccording to the independent patent claims. The dependent patent claimsdescribe embodiment devices of the inventive device and/or of theinventive process. This object can also be achieved by means of adigital memory medium, by means of a computer program product and bymeans of a computer program, which imparts to the medical device thefunctionality of the patent claims when installed in a medical device.

The medical device may have a control unit, which is equipped forautomatic starting of the medical device at a predetermined point intime and for checking, after a start of the medical device, to ascertainwhether a predetermined event has occurred. Furthermore, the medicaldevice may have a display screen for display of information if the checkreveals that the event has not occurred.

The control unit may be configured, so that, as a result of the check,it causes the display screen to display the information without anyfurther interaction on the part of a user. In other words the controlunit may be configured to send a signal to display the information tothe display and the information can be displayed without handling by auser. This automatic display can, but need not necessarily in all cases,be displayed on a surface of the display screen, which is presented tothe user on start-up of the device immediately or without furtherinteraction on the part of the user. The medical device may beconfigured, so that other messages and/or warnings and/or alarm messagesare displayed to more or less cover the information. The medical devicemay be configured, so that these other messages and/or warnings and/oralarm messages must first be removed by the user before the informationis automatically visible. This removal may include an acknowledgementand/or a shifting and/or a reduction in size of these other messagesand/or warnings and/or alarm messages. However, the device may also beconfigured, so that, for display of information, it is not necessary tocontrol a certain page in a menu structure for operation of the device.The system control and the display may be configured, so that the usermust necessarily have the information displayed before he can begin atreatment with the medical device.

The event may be the start-up of the medical device at a predeterminedpoint in time or control of an actuator or a sensor and/or the runningof a predetermined process. This process may be a cleaning process, inparticular a rinse process and/or a disinfection process and/or ahot-cleaning process. The control may also be part of such a process.

The medical device may have a time recording device for recording timeinformation. The check may include a comparison of the point in time ofstart-up of the medical device by means of the time recording device,detected by means of the time recording device, with the predeterminedpoint in time, and the display may take place when the time lies atleast a predetermined amount after the predetermined point in time.

The medical device may be configured, so that, when there is an auto-on,the predetermined point in time is set at the time of a new auto-onpoint in time. This makes it possible to ensure that comparing this timewith the predetermined point in time allows detection of whether anauto-on event has been “missed.”

The auto-on event may include predetermined process steps or one or moreadjustable and/or selectable process steps, for example, one or more ofthe cleaning processes described above. Then the new auto-on point intime can be set only when the set and/or selected process steps havebeen carried out completely.

The predetermined or selectable process steps and/or processes mayinvolve at least one process step from the group of the followingprocess steps: heat disinfection, rinsing, degreasing, colddisinfection, integrated hot cleaning with a cool-down phase, systemtest. The individual process steps are known from the state of the artand are used in the dialysis machine 5008 from Fresenius Medical Care,for example. They are described below only briefly. Heat disinfection—inthis case, disinfectant is heated and passed through line segments ofthe medical treatment machine. Rinsing is done only with water in aprocess similar to that of heat disinfection and the water can also beheated or, in another embodiment, this may be omitted. Therefore,residues of a previous disinfection, for example, can be rinsed out.Degreasing and cold disinfection also function like heat cleaning, butin this case different chemicals are added to the liquid and/or theliquid is not heated. In integrated heat cleaning, the liquid heatedoutside of the medical device can be sent through the medical device. Asystem test may include one or more steps, by means of which thefunctionality of the device is tested. These steps may include checkingthe sensors and/or the actuators of the device or a leakage test on theline system or functioning of the electronic system of the device.

The medical device may have a memory for storing event information whenthe event has occurred and the check may also include readout of theevent information.

The check may include a comparison of the time information in start-upof the device with the predetermined point in time and, if the currenttime information occurs later than the predetermined point in time, itmay include readout of the event information.

The medical device may have a sensor, in particular a conductivitysensor, a pressure sensor, a temperature sensor for detecting a propertyof a liquid in the medical device and the check may include a comparisonof the detected property with a preset value.

The medical device may be a device for a blood treatment, in particularan extracorporeal blood treatment device and/or a dialysis machine. Thedevice may be a hemodialysis machine, a peritoneal dialysis machine, aplasmapheresis machine or a liver assist therapy device.

The information shown on the display screen may include an interactiveinput element, which, on activation by the user, causes the control unitto start a process, in particular a cleaning process. The cleaningprocess may be one of the cleaning processes described above.

The control unit may be configured to display a selection of one or moreoptions for setting the medical device by the user and the displayscreen. This display of options may include the representation of theinformation described above as a result of the check.

A first option may include a first cleaning process and a second optionmay include a second cleaning process, wherein the duration of the firstcleaning process is greater than the duration of the second cleaningprocess.

The medical device may have a user interface for turning the check onand off. When the check is turned off, at least one process can becarried out automatically after starting the device. The automaticallyexecuted process may be a process which is saved in a memory in thedevice as a process to be carried out automatically in the event of anautomatic start-up of the device for the predetermined process.

One process for operating the medical device in a preparatory mode mayinclude the following steps:

After a start-up of the medical device, a check for whether apredetermined event has occurred, wherein the medical device is equippedfor automatic start-up at a predetermined point in time and display ofinformation when the check has revealed that the event has not occurred.

Furthermore, the check may include a comparison of a start-up time withthe predetermined point in time.

A digital memory medium and/or a computer program product can impartfunctionality to the medical device according to the process, asdescribed in the previous paragraphs, when installed in a medicaldevice.

DETAILED DESCRIPTION ON THE BASIS OF THE DRAWINGS

FIG. 1 shows a first embodiment of the medical device;

FIG. 2 shows a dialysis machine as an embodiment of the medical device;

FIG. 3 shows a sequence of a process for starting operation of a medicaldevice;

FIGS. 4 a )-c) show various embodiments of providing information forstarting up operation of a medical device, and

FIG. 5 shows another embodiment for providing information.

With reference to the figures, embodiments according to the inventionare described below, wherein means that have the same functional effectare referred to using the same reference numerals.

In all the embodiments, the use of the term “may be” and/or “may have,”etc. are to be understood as synonymous with “is in particular” and/or“has in particular,” etc. and/or should explain an additional embodimentaccording to the invention. Embodiments according to the invention mayhave one or more of the features defined above or below in anycombination as long as such a combination is not recognizablytechnically impossible for a skilled person.

Whenever numerical words are cited herein, the skilled person shouldunderstand them to be a statement of a lower numerical limit. If thisdoes not lead to a recognizable contradiction for the skilled person,and therefore the skilled person will always infer “at least one” whenthe specification is “one.” This understanding is also included in thepresent invention along with the interpretation that a numerical wordsuch as “one” can be interpreted alternatively to mean “exactly one,”whenever this is technically feasible for the skilled person. Both ofthem are covered by the present invention and apply to all numericalwords used herein.

FIG. 1 shows a schematic diagram of a medical device 1000 on the exampleof a fluid-carrying medical device 1000. The medical device 1000 has acontrol unit 1010, a timekeeping device 1020 and a display screen 1030.The control until 1010 is equipped for automatic start-up of the medicaldevice 1000 at a predetermined point in time and for checking on whethera predetermined event has occurred. If this check reveals that the eventhas not occurred, then the control unit is configured to send a signalto the display screen 1030 for display of information. The display ofinformation on the display 1030 may take place automatically without anyfurther action on the part of the user. This may also be understood toinclude the situation, wherein the menu guide of the medical device 1000is configured so that the user must necessarily have received a displaybefore he can carry out a treatment on a patient.

The control unit 1010 may have a processor, a memory and a communicationbus. Information can be saved in the memory. When this information isreviewed by a software routine carried out in the processor, the controlunit 1010 can ascertain whether the predetermined event has taken place.

This check may be a comparison of a start time with a predeterminedstart time saved in the memory, for example. The system control can beconfigured to interpret the fact that the start time occurs at least apredetermined amount of time after the predetermined start time, so thatthe event has not yet taken place. The predetermined start time may be atime that can be determined by the user.

The predetermined amount may be an amount greater than 0 minutes,greater than 5 minutes, greater than 10 minutes or greater than 20minutes. It is therefore possible to achieve the result that thestarting point in time is not compared directly but instead a laterpoint in time is compared. Therefore, actions which are to take placebefore the check according to the software being run can take placewithout having an influence on the result of the check. These actionsmay involve the run-up of the system, preceding tests or similaractions.

Alternatively or additionally, the system control may check at the timeof start-up to ascertain whether the event has actually occurred betweenthe predetermined point in time and the starting time. Therefore, whenthe event has occurred, an entry can be made in the memory, and thecheck may include readout of the memory entry by the control unit 1010.If the readout of the memory entry gives the result that the event hasnot occurred, then the control unit 1010 can send a signal to thedisplay screen 1030 to display the information.

The occurrence of the event may include the start of a process and/or aprocess step or a complete sequence of a process step and/or a process.

The event may include control of an actuator 1040 or a sensor 1040. Thecontrol may serve to carry out a predetermined process in the medicaldevice or to check the functionality of a part such as an actuator 1040or a sensor 1040. The event may include a cleaning process, inparticular a rinsing process and/or a disinfection process and/or aheat-cleaning process. The cleaning process may include heating of aliquid or a supply of a hot liquid from the outside, and may include ahot rinse process or a heat disinfection process. If the term “hot” isto be used, it should refer to at least 50° C., preferably 80° C., andthe liquid for rinsing or cleaning may be water and/or RO water. Theevent may include a check or calibration of a sensor 1040. To carry outthe process, the medical device 1000 may have a pump 1040 and a liquidsystem 1050, wherein the pump 1040 can be controlled by the control unit2010 in such a way that flow of a liquid through the liquid system 1050is generated. The sensor 1040 may have a conductivity sensor, a pressuresensor and/or a temperature sensor, by means of which the condition of aliquid in the liquid system 1050 can be determined for evaluating thestatus of the liquid or for evaluating the functionality of the sensor1040.

The timekeeping device 1020 may be a quartz oscillator or a clock, forexample. The signal of the timer 1020 can be transmitted to the controlunit 1010, and the time information can be processed in the control unit1010 in such a way that the medical device 1000 is started in the senseof an auto-on function according to time information saved in thememory, for example. The start-up may include automatic starting of theevent, for example.

The term “processor” is not limited here to a single physical processorbut instead the processor may also include a multi-core processor orsome other type of processors or processor components linked together.The memory may be a volatile memory and/or a nonvolatile memory or acombination of same. The memories and processors may be set up remotely,i.e., for example, on a central server, which is not physicallyconnected to a treatment module of the medical device 1000. The databuscan serve to exchange data between the memory and processor. Recordingwhether or not an event has occurred may include automatic filing of thecorresponding information in the memory. The term “filing” is to beunderstood to mean that non-filing is also included. The sensor devicemay thus read out a certain memory entry, and if the event has notoccurred, this memory entry will be different from what it would be ifthe event had occurred. The control unit may have the physical modulesof a computer, with which those skilled in the art are familiar andwhich are required in order to allow a program to run and thus tocontrol a medical device. In addition to the processor, memory andcommunication bus mentioned above, such modules may also includeinterfaces to the devices to be controlled, such as actuators, sensors,display, hardwired and wireless communication and the like.

The display screen 1030 can provide the information, for example, on agraphical user interface by means of lamps, by means of acoustic signalsor other display devices. The display screen 1030 may also include aninteractive device such as a touchscreen and/or one or more buttons. Dueto the interactive device the operator can send at least one instructionto the control unit 1010 in activation and send it for furtherprocessing by the control unit 1010. The further processing may involvecontrol signals to actuators and/or to the sensors of the medical deviceand/or processes that are complex in the implementation.

The medical device 1000 may be a hemodialysis machine 2000, asillustrated in FIG. 2 . The action described here is not limited to thehemodialysis machine 2000 of FIG. 2 , but instead may be used with anyhemodialysis machine and/or any medical device and/or dialysis machinewith an auto-on function, as will be apparent to those skilled in theart. The term “hemodialysis machine” includes all forms ofextracorporeal blood treatment machines, namely hemodiafiltrationmachines, plasma separation machines and ultrafiltration machines.

The hemodialysis machine 2000 may have a control unit 1010, a displayscreen 1030, and a timekeeping device 1020. Furthermore, thehemodialysis machine 2000 may have a pump 1040 for pumping a liquidthrough the liquid system 1050. The hemodialysis machine may have awater inlet 2010. The water inlet 2010 may be configured to be connectedto a water source (not shown), for example, to an RO system of a centralwater supply system. Furthermore, the hemodialysis machine 2000 may alsohave a disinfectant connection 2020. The water and/or the disinfectant2025 and/or a mixture of the two can be heated in a heating device 2030,for example, by carrying out a heat-cleaning process using water and/ordisinfectant. Furthermore, the hemodialysis machine 2000 may have atleast one concentrate connection 2040 and at least one concentrate pump2050 for connection and pumping of concentrates 2055 for preparing thedialysate by mixing it with water from the water inlet 2010, a balancingsystem 2060, optionally with an ultrafiltration pump 2070, at least onesterile filter 2080. Furthermore, the hemodialysis machine 2000 may havea bypass 2090, through which liquid flowing through the liquid systemcan be circulated. Bypass 2090 can be used when the dialyzer 2100 is notconnected to the liquid system 1050. Furthermore, the hemodialysismachine 2000 may have valves 20150, sterile filters 20160, accesses,short-circuit lines 20170, pumps, sensors. These are indicatedschematically in FIG. 2 , where those skilled in the art will understandhow these elements can be arranged in order for them to be able tomanifest their respective functionality.

For cleaning the hemodialysis machine 2000, water can be supplied to theliquid system 1050 via the inlet 2010 or dialysate can be suppliedthrough the disinfection connection 2020. Then it can be heated usingthe heating device 2030 in a chamber and sent through the bypass 2090 toan outlet 2110 of the hemodialysis machine 2000. Furthermore, the liquidsystem 1050 of the hemodialysis machine 2000 may have a circulationsection 2120. If the liquid is carried through this circulation section2120, it is sent upstream to a region of the liquid system 1050.Therefore the liquid can circulate in the hemodialysis machine 2000, forexample, in a circulation mode. This circulation mode may be part of acleaning process.

The control unit 1010 of the hemodialysis machine 2000 may have at leastthe same functionality as the control unit 1010 of the medical device1000 and may be constructed accordingly. A signal of the control unit1010 can control the at least one actuator of the hemodialysis machine2000 via signal lines (not shown) or may receive measured data from atleast one sensor of the hemodialysis machine 2000.

The display screen 1010 of the hemodialysis machine 2000 and thetimekeeping device 1020 may have at least the same functionality as thedisplay screen 1010 of the hemodialysis machine 2000 and the timekeepingdevice 1020 of the medical device 1000 and may be constructedaccordingly.

The hemodialysis machine 2000 may have a network connection 2130. Thehemodialysis machine 2000 can be supplied with power via this networkconnection 2130, for example, for the system control, the displayscreen, the actuators or the sensors. The hemodialysis machine 2000 canbe connected to a power source 2140. This power source 2140 may be abattery, which makes it possible to have some or all processes takeplace in the hemodialysis machine 2000, even without a connection viathe network connection 2130 to supply it with power and/or allowing itto run.

The control unit 1000 can carry out the check (FIG. 3 ). First, theauto-on function is activated 3000 by a user. In doing so, the user canascertain at which point in time the medical device 1000 should bestarted. Furthermore, the user can determine which processes should takeplace automatically after auto-on. This time and these processes can besaved. At least one action, which runs automatically when the device isstarted by means of the auto-on function, can also be saved. Examples ofthese processes and actions are described above, although the presentinvention is not limited to those.

When the machine is started 3010, the control unit 1010 checks 3020 onthe current time, comparing it with the saved auto-on time(predetermined time). If the current time is after the auto-on time oris after that time by a predetermined amount, then the system control1010 recognizes 3030 that the event has not occurred and outputs 3040information about the display screen 1030.

Alternatively or in addition to the recognition that the event hasfailed to occur on the basis of the comparison of the start time withthe auto-on time (steps 3020 and/or 3030), the control unit 1010 canmake 3050 an entry into a memory at start-up and/or occurrence of anevent. This may take place, for example, by means of a flag or a memoryentry at a dedicated memory location. If the medical device 1000 isstarted at a later point in time, the control unit 1010 then checks 3060the memory entry, and if the memory entry does not indicate that theevent has taken place, information about the display screen 1030 isoutput 3040.

If the check is additionally carried out according to steps 3050 and3060, then the display can take place only when both or at least one ofthe two checks has shown that the event has not occurred.

The information on the display screen 1030 may include a message 4000that the event has not occurred (FIG. 4 a ). Furthermore, theinformation may include an acknowledgeable message 4010, for example, anOK message. By acknowledging, the medical device 1000 can be put in aready-to-operate status in which a user can select additional processes.The information can also be acknowledged with two types ofacknowledgement. The first type of acknowledgement may be a permanentacknowledgement, in which the message does not appear again, and thesecond type may be a transient acknowledgement, in which thisinformation or some other information is displayed again after apredetermined period of time.

Alternatively or additionally, the information may include a selectablerepresentation 4020 (option) (FIG. 4 b ). When this representation 4020is selected, the user can choose the option that the event that has notoccurred is to be carried out. The displayed information 4020 mayinclude an interactive input element, which causes the control unit tostart a process as an event on activation by the user. This process maycomprise one or more of the actions described above, in particular acleaning process. This action may be the action which has not takenplace, for example, due to an auto-on start that has been missed.

Alternatively or additionally, the information may include anotherselectable representation 4030 (additional option) (FIG. 4 c ). Whenthis representation 4030 is selected, the user can choose the option ofcarrying out a predetermined event.

Due to the additional selectable representation 4030 in addition to theselectable representation 4020, the user is offered a choice of at leasttwo options for the user to make a setting of the medical device on thedisplay screen. A first option may include a first cleaning process anda second option may include a second cleaning process, wherein theduration of the first cleaning process is longer than the duration ofthe second cleaning process.

In another embodiment, which is represented schematically in FIG. 5 ,information 5000 informing the user about possible causes for thedisplay of the information 4000 may be displayed on the display screen1030 in addition to the information 4000 and the acknowledgeableinformation 4010. This additional information may instruct the userabout possible actions the user himself may perform on the machine. Themachine may also be configured, so that it saves at least the point intime of the most recent occurrence of an event and displays this pointin time for the user when it is an event that was not carried out 5010due to the non-occurrence of the automatic start. This can make itpossible for the user to estimate whether it is necessary to actuallycarry out this event and/or process.

The acknowledgeable information 4010 may result in a permanentdisappearance of the information. A second type of acknowledgeableinformation 5020 can also be displayed. With this type of information,the device is configured to display this information again after apredetermined period of time.

The embodiment disclosed in conjunction with the embodiment described onthe basis of FIG. 5 can also be combined with any of the embodimentsdescribed on the basis of FIG. 4 or any embodiment according to theinvention.

Furthermore, the medical device 1000 may have a user interface foractivating and deactivating the check. The display screen 1030 oranother input means may be this user interface. The display screen 1030may be a touchscreen but additionally or alternatively, it may be anyother type of information transfer, such as LEDs, lamps and as aninteractive means, buttons, switches or the like.

The medical device may be configured to automatically carry out at leastone process when the check is turned off after starting the device. Theprocess carried out automatically may be a process which is saved in themedical device in a memory as a process to be carried out automaticallyin an automatic start of the device for the predetermined process.

Due to the check described above, it may be possible to operate themedical device more safely. For example, an auto-on start may be misseddue to the fact that the machine is not connected to the network at thetime of the auto-on start or there has been a power failure.Furthermore, there may also be a difference in the times of varioustimekeeping devices present in the device whose outputs are used todetermine the current time and to determine the point in time when anevent occurred. However, it may also be the case that the device isalready running at the time of the auto-on and the event cannot occur.

The invention claimed is:
 1. A process for operating a medical device ina preparation mode, comprising the steps: starting the medical device,checking after starting the medical device on whether a predetermined,automatically carried-out event has occurred before starting the medicaldevice, wherein the medical device is equipped for automatic start at apredetermined point in time, and display of information when the checkhas revealed that the event has not occurred.
 2. The process accordingto claim 1, wherein the check comprises a comparison of a starting timewith a predetermined point in time.
 3. The process according to claim 1,wherein a control unit of the medical device automatically starts themedical device at a predetermined point in time and, after start-up ofthe medical device, checks on whether the predetermined event hasoccurred, and a display screen displays the information when the checkhas shown that the event has not occurred.
 4. The process according toclaim 3, wherein the control unit sends a signal to display theinformation to the display screen, and the information is displayed onthe display screen without any action by a user.
 5. The processaccording to claim 3, wherein the event includes starting the medicaldevice at the predetermined point in time and/or controlling an actuatoror a sensor and/or running a predetermined process.
 6. The processaccording to claim 3, wherein the predetermined point in time isrecorded on a time recording device of the medical device, wherein thechecking includes comparing the time of start-up of the medical devicewith the recorded predetermined point in time, and wherein the displayoccurs when the time of start-up occurs at least a predetermined amountafter the predetermined point of time.
 7. The process according to claim3, wherein a memory of the medical device stores event information whenthe event has occurred, and wherein the checking includes readout of theevent information when the event has occurred.
 8. The process accordingto claim 3, wherein a sensor of the medical device detects a property ofa liquid in the medical device, and wherein the checking includescomparing the property thus detected with a preselected value.
 9. Theprocess according to claim 3, wherein the process is an extracorporealblood treatment and/or a dialysis.
 10. The process according to claim 3,wherein the display displays an interactive input element, whichinteractive input element, on activation by a user, causes the controlunit to start a process.
 11. The process according to claim 3, whereinthe display displays, for selection by a user, at least one option foradjustment of the medical device.
 12. The process according to claim 11,wherein a first option of the at least one option is a first cleaningprocess and a second option of the at least one option is a secondcleaning process, wherein the duration of the first cleaning process islonger than the duration of the second cleaning process.
 13. The processaccording to claim 3, wherein the medical device has a user interfacefor turning the checking on and off, and wherein the device isconfigured to carry out at least one process automatically when thechecking is turned off by a user after a start-up of the device.
 14. Theprocess according to claim 13, wherein a memory of the medical devicesaves the automatically executed process for automatic execution with anautomatic start of the device.